A senior Danish GCP Inspector highlights instances of clinical trial sites facing burdensome procedures to support decentralized trials and discusses other challenges posed by such studies.
Decentralized trials (DCTs) can make research faster and more efficient as they allow all or most trial activities to be done remotely in or near a patient’s home. However, if not designed or executed well, such studies can miss the efficiency goal.
The Danish Medicines Agency has come across several instances of clinical trial sites being placed under “undue pressure” to support...
<p>Executive Summary</p> <p>A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.</p>
As the reform of the EU pharmaceutical legislation progresses through the legislative process, the Pinks Sheet offers an infographic highlighting some of the key changes being proposed that will reshape the way drug companies run their business.
<p>Executive Summary<p> <p>The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add six new products, incl/ding Ixchiq, Valneva's chikungunya virus vaccine</p>
The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.
A new research ethics review system for multi-site clinical trials in Canada is expected to help improve study start-up times, avoid unnecessary duplication and boost the country’s competitiveness on a global stage.
